Consultant at Cornerstone International
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Manager - Regulatory Affairs - Pharma (6-15 yrs)
About the client:
- Company Name: Althera Pharmaceuticals
- Industries: Pharmaceutical & Life Sciences
- Company Type: Forbes Global 2000
- Headquarter Location: Bangalore
- Nature of Offering: Service
- Founding Year: 2010
- No of Employees: 51-200
Job Summary Description :
Experience expected: 6 to 10 years in Regulatory Affairs/Regulatory operations with significant focus on EU variations filings, especially for oral solid dosages. Additional experience in European markets and other dosage forms such as creams and injectables a plus, but not a necessity.
Following are the expectations from this role:
1. EU EMA Submissions management: Preparation, execution, submission and submission management of Althera or its affiliates' products, such as(non-exhaustive):
a. Perform detailed regulatory review and assessment of all documents, gather required data as needed to develop/finalize the documents, coordinate and prepare submissions.
b. Review technical reports, summary documents and change controls (chemistry, manufacturing and analytical controls) for appropriate content and justifications as well as for adherence to regulatory guidelines, strategies, and commitments.
c. Manage, prepare, and publish, using eCTD software (such as Lorenz docubridge , etc), well-organized, scientifically sound submissions for Althera or its affiliates products related to New Marketing Authorizations, Amendments, Annual reports, PSUR, and Supplements that comply with applicable regulatory requirements in eCTD format.
d. Publish submissions on the e-submissions platform.
e. Post-approval variations filing
f. Other Legal and regulatory related submissions as may be required.
2. Interaction with Regulatory Agencies: Regular interaction with various EU Health Authorities in the preparation, pre-approval and post-approval management of Company or its affiliate's products, such as (non-exhaustive):
a. Communicating with project coordinators and others at EU Health Authorities or other regulatory agencies (or regulators) including but not limited to Variations
b. Requesting slots for meetings.
c. Preparing for regulatory meetings.
d. Coordinating internally on preparatory materials or conversations with regulators.
e. Responding to e-mails or phone conversations.
f. Sending and receiving documents (electronic and paper).
g. Other Legal and regulatory related interactions with agencies as may be required.
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